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Quality Management

Run every internal and supplier audit
to closure

Plan each internal and supplier audit, give every finding an owner and a due date, and close it with the evidence attached.

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Audit where the gaps are

Compliance Frameworks assesses your records against every clause of ISO 13485, the QMSR or cGMP. Start the internal audit plan from the clauses with open gaps, and spend the audit on what the records can't show: how the work is done on the floor.

Qualio compliance frameworks view showing clause coverage and open gaps for ISO 13485 and EU MDR Annex II and III

Every finding closes against its clause

Each finding is a task with an owner and a due date, linked to the clause it concerns. One that needs investigating opens a CAPA, or a SCAR on the supplier. When the fix changes the records, Qualio reassesses the clause and the gap closes with it.

CAPA-034 moving from the quality event through root cause, corrective action and effectiveness check, with its audit trail

The auditor asks by clause, and the evidence is filed under it

Procedures with their approvals, training records, CAPAs and supplier files sit under the clauses they answer. Export the audit pack by clause, with past internal audits and their findings on file beside it.

Qualio document library listing controlled SOPs and procedures with their type and version

Platform connections

CAPAs and SCARs

A CAPA or SCAR opened from a finding runs in the same flow as your deviations and complaints. See quality events.

Suppliers

Supplier audits follow each supplier's risk ranking, and a supplier's findings stay on its record. See suppliers.

Copilot

It answers the auditor's question from your records, citing the documents and events it read, and drafts the CAPA investigation from a finding. Your team approves it before anything closes.

Frequently Asked Questions

What is an internal audit?

An internal audit is a planned check, carried out by your own people, that the quality system runs as its procedures say and meets the standard you are certified or inspected against. ISO 13485 clause 8.2.4, ISO 9001 clause 9.2 and EU GMP Chapter 9 each require a programme of them, with findings recorded and acted on.

How do audit findings become CAPAs in Qualio?

Each finding is a task on the audit event, with an owner, a due date and the clause it concerns. A finding that needs a root cause investigation opens a CAPA from the event, and a finding against a supplier opens a SCAR on that supplier. The audit shows which findings are open and which are closed.

Does Qualio support 21 CFR Part 11 for audit records?

Yes. Audit events, their findings and their closures keep an audit trail of who did what and when, and approvals are signed electronically with the signer's name, the date and time and the meaning of the signature.

Can we manage an FDA inspection or a notified body audit in Qualio?

Qualio doesn't run the inspection itself. It holds the procedures, training records, CAPAs and supplier files the inspector asks for, with the audit trail behind each one, and exports the audit pack by clause through Compliance Frameworks. Observations the inspector leaves are raised as CAPAs.

Which finding from the last audit is still open?

Bring it to the demo and we will raise it on an audit event, link it to its clause, open the CAPA and close it with the evidence attached.

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